- The expansion of Soligenix’s European Medical Advisory Board underscores the company’s commitment to delivering innovative treatment options to European patients.
- HyBryte (synthetic hypericin) is a first-in-class, photodynamic therapy using synthetic hypericin as a photosensitizer.
- The company’s efforts could establish HyBryte as a new standard of care for patients who currently have limited options.
Cutaneous T-cell lymphoma (“CTCL”) is a rare but serious form of non-Hodgkin lymphoma that primarily affects the skin. Globally, millions suffer from CTCL, and in Europe, the annual incidence is estimated at 2.9 to 3.9 cases per million people (https://ibn.fm/ANk8X). Despite its rarity, CTCL presents a substantial unmet medical need, particularly in early-stage patients who often have limited treatment options. Addressing this gap, Soligenix (NASDAQ: SNGX) recently announced the expansion of its European Medical Advisory Board (“MAB”) (https://ibn.fm/6354Y) to provide additional clinical and strategic guidance as the company advances its confirmatory phase 3 study (referred to as FLASH2) evaluating the safety and efficacy of its proprietary CTCL treatment: HyBryte(TM).
The expansion of Soligenix’s European MAB underscores the company’s commitment to delivering innovative treatment options to European patients. The announcement also notes a strategic step to ensure the successful execution of FLASH2 and to navigate the complex regulatory and clinical landscape across European countries.
By bringing together leading experts in dermatology and oncology, the board will provide critical insights into clinical development, regulatory compliance, and market access strategies. This collaboration will help align Soligenix’s development plans with the unique needs of European patients and healthcare providers, ensuring that HyBryte’s advancement is guided by both scientific rigor and practical considerations for real-world application.
HyBryte (synthetic hypericin) is a first-in-class, photodynamic therapy using synthetic hypericin as a photosensitizer. When applied topically and activated by visible light, it targets malignant T-cells within lesions while sparing surrounding healthy tissue. Soligenix’s initial phase 3 FLASH study successfully achieved its primary endpoint and demonstrated a 49% response rate at 18 weeks of treatment in patients with early-stage CTCL, providing strong evidence of its potential clinical benefit (https://ibn.fm/Yl6JC). Building on these findings, the ongoing FLASH2 study is a randomized, double-blind, placebo-controlled, multicenter trial enrolling approximately 80 patients. It aims to confirm and extend previous results, evaluating the therapy’s efficacy and safety during an 18-week treatment period, with top-line results expected in the second half of 2026.
Looking ahead, Soligenix’s initiatives with HyBryte have the potential to significantly impact CTCL treatment in Europe. By focusing on early-stage disease with a localized, non-invasive therapy, the company aims to offer effective disease control while minimizing side effects, a combination rarely seen in current treatment regimens. The European MAB expansion further strengthens Soligenix’s ability to deliver on this promise, providing expertise to guide clinical execution, regulatory strategy, and patient access. Combined with the results of the FLASH2 trial, these efforts could establish HyBryte as a new standard of care for patients who currently have limited options.
Soligenix’s work on CTCL also reflects a broader commitment to addressing rare and underserved diseases. By leveraging innovative therapeutic approaches and expert guidance, the company is positioning itself to improve both clinical outcomes and patient quality of life. With a clear pathway for near-term clinical validation and strategic advisory support in Europe, Soligenix is not only advancing its pipeline but also addressing a critical gap in oncology care. These efforts demonstrate the company’s dedication to providing meaningful, effective and accessible treatment options for CTCL patients across Europe.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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